K860051 is an FDA 510(k) clearance for the MODEL 8604 OXYGEN/PULSE MONITOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Nonin Medical, Inc. (White Bear Lake, US). The FDA issued a Cleared decision on June 5, 1986, 150 days after receiving the submission on January 6, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K860051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1986 |
| Decision Date | June 05, 1986 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |